The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Advance Nxi Pet System.
| Device ID | K003849 |
| 510k Number | K003849 |
| Device Name: | GE ADVANCE NXI PET SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | D Duersteler |
| Correspondent | D Duersteler GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2000-12-22 |